Apologizing to Guatemala — and Perjury at Nuremberg

by Kevin Jon Heller

Obama apologized on Friday for experiments conducted in Guatemala between 1946 and 1948 in which American scientists deliberately infected prison inmates, prostitutes, and mental patients with syphilis without their consent. The apology is a striking reminder that the Nazis were not the only ones that conducted horrific, non-consensual medical experiments on human subjects in the first half of the 20th century (although, to be sure, the Nazi experiments were vastly more brutal than any conducted by American scientists). Indeed, America’s own sordid history of medical experimentation led to the worst example of perjured testimony during the Nuremberg Military Tribunals. From Chapter Four of my book:

The misconduct involved Andrew Ivy, the head of the University of Illinois at Chicago’s Medical College, who was the prosecution’s star expert witness at trial.Prior to his testimony, he was present during the cross-examination of another prosecution witness, Walter Leibrandt, a professor of medical history at the University of Erlangen, who had testified that experimentation on humans was unethical even if the subjects consented and the experiments had medical value.On cross, Leibrandt admitted that the standard he endorsed condemned not only the defendants’ experiments, but also American malaria experiments conducted on inmates at Stateville Prison in Illinois during the war.Concerned by Leibrandt’s testimony, Ivy decided to defend the Stateville experiments by testifying that they had been overseen and approved by a public ethics committee.No such committee had existed, however, much less one that approved the experiments.

Undaunted, Ivy returned to the United States and convinced the Governor of Illinois, Dwight Green, to form an ad hoc committee – the Green Committee – to advise him on the ethics of medical experimentation on human subjects.Ivy did not tell the Governor that he intended to testify when he returned to Nuremberg, the committee never met, and the committee’s “report” was authored by Ivy himself.Ivy nevertheless not only claimed at the Medical trial that the Green Committee had approved the Stateville experiments, he responded to a defense question about whether “the formation of the committee had anything to do with the fact that this trial is going on” by testifying that “there is no connection between the action of this committee and this trial.”It is unlikely that the prosecution was aware of the true facts – but it is beyond question that Ivy blatantly perjured himself.

In an interesting move, the Medical tribunal permitted two defendants in the case, Ruff and Rose, to personally cross-examine Ivy. Rose’s questioning was extremely effective — so effective, in fact, that the judges suddenly decided to limit him to 30 minutes of cross-examination!

That’s just a snippet from the book. If you want to learn more, you’ll just have to buy it…

8 Responses

“Over the past 20 years or so, without much fanfare, clinical research has undergone a remarkable free-market conversion. Until the early 1990s, most pharmaceutical research on human subjects was conducted by physicians in universities and teaching hospitals. (The FDA, which must approve drugs before they can be marketed, doesn’t conduct clinical trials itself.) However, pharmaceutical companies have been in search of cheaper, more efficient venues and today about 70 per cent of clinical trials take place in the private sector, often in the offices of private physicians or at dedicated sites. Clinical research has become a multibillion-dollar global industry, spawning spin-off businesses that barely existed 25 years ago, from patient recruitment firms and medical communication agencies to for-profit research ethics boards.”

As to the sordid part:

“It is striking just how little is known about the new clinical trials industry. Partly this is because it is so widely dispersed. Back in the old days, if you worked in a medical school or teaching hospital, you could often get a feel for a clinical trial simply by walking down the hall. Now you might need to go to India or Uzbekistan. Even if you restricted yourself to domestic studies, you would log a lot of miles trying to visit all the various stations in the production line. The trial itself might take place at fifty different sites, ranging from Ivy League teaching hospitals to a business park near Toronto airport. The ethics committee approval would probably come from Olympia, Washington; the subject recruitment could be managed in Dallas, Texas; and the trial results might be written up in Princeton, New Jersey. It is no wonder only industry insiders seem to know exactly what is going on. When Bloomberg reporters discovered that SFBC International was paying immigrants to be test subjects in a dilapidated former Holiday Inn in Miami, SFBC had recently been named one of the best small businesses in America by Forbes magazine. The Holiday Inn testing facility was the largest in North America, and had been operating for nearly ten years before inspectors noticed there was anything wrong. [….]

What does clinical research look like when everyone is in it for the money? For a start, it looks a lot less like science. ‘I do not do original research; I do contract research,’ says a private physician-researcher in Medical Research for Hire. A contract researcher does not come up with original ideas, or design research protocols, or analyse research results, or write them up for scientific publications. All of this is done by the pharmaceutical company or its hired specialists. What a contract researcher does is recruit subjects, monitor their clinical care and sign off on the paperwork. Not a lot of original work is done, and in some cases, not much work at all (a running joke has it that physicians do clinical trials in order to improve their golf games). The industry term for these near absent physicians is ‘phantom investigators’. Usually they will ‘come in on a daily basis, on most days, and they’ll sign off on all the things they need to sign off on, see any patients they need to see, and they’re gone,’ a study monitor says to Fisher. The researchers are usually on-site for no more than an hour or two a day.

Contract researchers may not do much intellectual work, but this doesn’t mean they are not well paid. A part-time contract researcher conducting four or five clinical trials a year can earn an average of $300,000 in extra income. In 2000, a full-time clinical trial site earned an average of $1.6 million. According to Fisher, any given service will generate between two and five times as much money for a physician when a pharmaceutical company is paying the bill as when a health insurance company or a government agency is paying. Even an ordinary office visit will be paid at twice the usual rate if the visit is part of a research study. Some physicians sign up as contract researchers for the same reasons they might peddle nutraceuticals or dispense cosmetic Botox injections. It is a way to make extra money.

However, the most valuable commodity in the contract research business is not the physician. It is the patient: ideally, the sort of patient that the industry calls ‘ready to recruit’. Ready to recruit patients are sick people who can easily be persuaded to enrol in clinical trials, often because they are so poor that they have no better alternative. If a patient can be persuaded to enrol in a study quickly, so much the better: drug patents last only 20 years, and the patent clock ticks down while the drug is being tested. Four out of every five clinical trials are forced to extend their timelines because of recruiting delays. [….]

The pool of potential subjects is gradually becoming depleted, in part because so many subjects in North America and Western Europe are taking other medications, which will often exclude them from enrolling in trials. Drug companies need ‘treatment-naive’ subjects, who, like the ‘ready to recruit’, are easier to find in the developing world. In 1991, only 10 per cent of clinical trials were conducted in emerging markets; by 2005, that figure had increased to 40 per cent.

According to Adriana Petryna’s When Experiments Travel, the most popular place for new trial sites is Central and Eastern Europe; there are plenty of sites, too, in the Asia-Pacific region. Between 1995 and 2006, the highest annual increases in the number of active clinical researchers occurred in Russia, Argentina, India, Poland, China and Brazil. Many of these places have established a foothold in the industry as ‘rescue countries’: drug companies go there when they need data quickly – when their trials in the West have failed to show the drug is effective, for example, or when they have been unable to recruit enough subjects. Poland has been a popular place to test urology drugs and asthma drugs, a Czech physician tells Petryna; the Czech Republic has been a good spot for antibiotics and arthritis drugs. ‘There were treatment-naive, steroid-naive, statin-naive people – people you could hardly find in the US or Western Europe,’ the physician explains. ‘We had extremely high recruitment rates.’

The move into Eastern Europe began with the ‘opportunity’ phase, or the gold rush, when the trials industry first discovered the rescue countries. In the early post-Soviet years, clinical trials were easy to launch. ‘No one cared about the content of the investigations,’ the Czech physician says. ‘Ethical approval was a mere formality.’ There followed a ‘normalisation’ phase, when the trials became a routine, accepted part of healthcare. Over time, patients no longer saw them as experimental, but as part of their standard medical treatment. Finally came the ‘exhaustion’ phase. Too many companies were competing for subjects; the subjects began to get choosy; regulations began to tighten. So the clinical trials industry began to move further east – to Russia, for example, Ukraine, Uzbekistan and Kazakhstan.

The move to poorer countries intensifies the ethical problem created by a market-based trial system. The patients have even less access to standard medical care than patients in the US, and by enrolling in trials they can get drugs that they could not otherwise afford – never mind that the drugs are experimental, or may be placebos. Physicians who are paid handsomely to recruit their patients for trials will often find the money hard to resist, since they make so little practising ordinary medicine. ‘In Russia, a doctor makes $200 a month,’ a contract research executive tells Petryna, ‘and he is going to make $5000 per Alzheimer’s patient.’ [….]

By turning clinical research over to the market we have created a system in which private physician-investigators can make far more money persuading their patients to enrol in research studies than by simply treating their illnesses; in which patients sign up to test new drugs, either because they need the money or because they have no way to pay for ordinary healthcare; in which investigators are financially punished for telling companies that their drugs are risky or dangerous; and in which even ethical oversight has become a revenue-generating mechanism. Lost in this business model are the human research subjects themselves. As a CRO manager in Eastern Europe tells Petryna, apparently without irony: ‘We don’t see patients, we see data.’”

Medical testing without consent is precisely the type of outrageous misconduct found to be a violation of international law by the Second Circuit in Pfizer. In the Pfizer case, the court found Pfizer had violated int’l law (by testing its experimental anti-meningititis drug, Trovan, on Nigerian children) and could be brought to trial under the ATCA for the resultant injuries. Of course, after Kiobel, which held corps cannot be liable under int’l law and thus not liable under the ATCA, this type of abuse of non US citizens can be done with impunity – violate int’l law and get a free pass if you are a corp defendant.

10.04.2010
at 1:40 pm EST JohnnieWalkerBlue

In the Pfizer case, the court found Pfizer had violated int’l law (by testing its experimental anti-meningititis drug, Trovan, on Nigerian children) and could be brought to trial under the ATCA for the resultant injuries.

I was under the impression there was never a ruling on the merits of that case…

On review of a district court’s grant of a motion to dismiss, we assume as true the facts alleged in the complaints, construing them in the light most favorable to the appellants.

I don’t think that’s a consideration on the merits.

10.06.2010
at 9:02 pm EST M. Gross

Read the opinion instead of taking a couple of snippets from the outset. And by the way, its standard procedure for U.S. appellate courts to “assume the truth” for purposes of the motion in other words they construe the facts in the light most favorable to the opposing party (here the plaintiffs who were opposing Pfizer’s motion at the dist ct). In other words the 2d Cir assumed that Pfizer really did the things alleged – they are not saying it really happened (has to be proven via admissible evidence at trial). The appellate ct does not require pls to actually prove the facts at this stage. If you take the time to read the opinion it clearly goes through the conventions and CIL on medical testing. The ct says there is a colorable claim under the ATCA – medical testing without consent violates CIL.

10.07.2010
at 1:09 am EST JohnnieWalkerBlue

Why is it that we always have to compare guilt back to the Nazis? I am sorry, but the sentence “although, to be sure, the Nazi experiments were vastly more brutal than any conducted by American scientists” seems ill placed. The inhumanity of some Nazi experiments defies the imagination. But American scientists making syphilis-infected prostitutes sleep with mental patients and prison inmates, inflicting abrasions to “improve” contagion and ultimately in some cases puncturing their spines to deliver the disease are precisely like Nazi scientists doing the same thing. The fact that some Nazi scientists did worse is besides the point (so that is the standard we are comparing American science with these days?).

10.07.2010
at 2:44 am EST anon

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